Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Occurrence of causally related serious <br/ >adverse events (SAEs) throughout the study duration following vaccination <br/ > <br/ >Immunogenicity Outcomes: <br/ >a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2 <br/ > <br/ >Safety Outcomes: <br/ > <br/ >a. Occurrence of solicited local and systemic AEsTimepoint: Throughout the study follow up period <br/ > <br/ >14 days after second vaccination (35 days post first dose vaccination) <br/ > <br/ >For 7 days following each dose <br/ > <br/ >35 days post first dose vaccination <br/ > <br/ >Throughout the study period following vaccination

Occurrence of causally related serious <br/ >adverse events (SAEs) throughout the study duration following vaccination <br/ > <br/ >Immunogenicity Outcomes: <br/ >a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2 <br/ > <br/ >Safety Outcomes: <br/ > <br/ >a. Occurrence of solicited local and systemic AEsTimepoint: Throughout the study follow up period <br/ > <br/ >14 days after second vaccination (35 days post first dose vaccination) <br/ > <br/ >For 7 days following each dose <br/ > <br/ >35 days post first dose vaccination <br/ > <br/ >Throughout the study period following vaccination

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

March 26, 2021, 2:21 p.m. oms

Occurrence of causally related serious <br/ >adverse events (SAEs) throughout the study duration following vaccinationTimepoint: Day 36; 85; 180

Occurrence of causally related serious <br/ >adverse events (SAEs) throughout the study duration following vaccinationTimepoint: Day 36; 85; 180